The following data is part of a premarket notification filed by Ceramay Gmbh & Co.kg with the FDA for Dcceram System.
| Device ID | K141400 |
| 510k Number | K141400 |
| Device Name: | DCCERAM SYSTEM |
| Classification | Powder, Porcelain |
| Applicant | CERAMAY GMBH & CO.KG 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Contact | Pamela Papineau, Rac |
| Correspondent | Pamela Papineau, Rac CERAMAY GMBH & CO.KG 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-28 |
| Decision Date | 2015-01-28 |
| Summary: | summary |